The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation

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Conditions studied: Low Back Pain, Amputation

In brief

Patients with combat-related lower limb amputations frequently experience chronic low back pain during long-term rehabilitation and prosthetic use. Altered biomechanics, asymmetric loading, gait disturbances, and changes in spinal alignment after limb loss may contribute to the development of persistent back pain. The severity and characteristics of low back pain may vary according to the level of amputation. The LEVEL-BACK Study is a prospective observational study designed to evaluate the relationship between amputation level and chronic low back pain after combat-related amputation. Participants with different levels of lower limb amputation will undergo clinical assessment of low back pain intensity, functional limitations, prosthesis use, and rehabilitation outcomes during follow-up. The goal of the study is to improve understanding of how amputation level influences chronic low back pain after combat-related limb loss and to identify patients at increased risk for persistent spinal pain during rehabilitation.

Key facts

Study ID

NCT07626294

Run by

Ukrainian Society of Regional Anesthesia and Pain Therapy

People needed

300

Starts

2026-09-15

Expected to finish

2026-09-15

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Combat-related lower limb amputation
• Transtibial, transfemoral, or bilateral lower limb amputation
• Time since amputation ≥3 months
• Current or planned prosthesis use
• Ability to participate in rehabilitation assessment
• Ability to report low back pain intensity
• Ability to provide written informed consent

You may not qualify if…

• Traumatic spinal injury related to the initial combat trauma
• Previous spinal surgery before amputation
• Known severe spinal deformity
• Active spinal infection or malignancy
• Severe neurological disorder affecting mobility
• Non-combat-related amputation
• Inability to complete follow-up assessments
• Refusal or inability to provide informed consent

Where it is running

• Vinnitsya university hospital — Vinnytsia, Ukraine

Full record on ClinicalTrials.gov

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